Is Loperamide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Loperamide, including IMODIUM 2MG CAPSULE (2 mg, Capsule, SAR 6.45); IMODIUM INSTANTS 2MG ORODESPERSIBLE TABLET (2 mg, Tablet, SAR 12.40).

Is Loperamide approved by the US FDA?

Drugs@FDA lists 40 application product lines for Loperamide, including IMODIUM A-D (Over-the-counter); IMODIUM A-D (Over-the-counter); LOPERAMIDE HYDROCHLORIDE (Prescription); LOPERAMIDE HYDROCHLORIDE (Prescription); LOPERAMIDE HYDROCHLORIDE (Over-the-counter).

Is Loperamide on the WHO Model List of Essential Medicines?

Yes — 2.3. Medicines for other common symptoms in palliative care (core list): Palliative care.

Are there safety signals or safety updates for Loperamide?

EMA PRAC: 4 entries; US FDA: 8 entries; MHRA: 1 entry (latest 2019-08-07).

Active substance

Loperamide

SFDA 4
US FDA 40
Health Canada 14
US price lines 2
NHS prices 5
WHO EML 1
Safety 13

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
IMODIUM 2MG CAPSULE	2 mg	Capsule · Oral use	6 Blister	SAR 6.45	Generic · OTC	MCNEIL PRODUCTS LIMITED	Valid
IMODIUM INSTANTS 2MG ORODESPERSIBLE TABLET	2 mg	Tablet · Oral use	6 Blister	SAR 12.40	NCE · OTC	MCNEIL PRODUCTS LIMITED	Valid
IMODIUM INSTANTS 2MG ORODESPERSIBLE TABLET	2 mg	Tablet · Oral use	12 Blister	SAR 22.35	NCE · OTC	MCNEIL PRODUCTS LIMITED	Valid
LOPODIUM 2MG CAPS	2 mg	Capsule · Oral use	10 Blister	SAR 3.35	NCE · OTC	MEMPHIS CHEMICALS	Withdrawn by regulatory authority · Not Marketed

Indications — CHI Daman Drug Formulary

BREAST CANCER EARLY HER-2 -VE -ADVERSE REACTION MANAGEMENT; BREAST CANCER HER-2 +VE-ADVERSE REACTION MANAGEMENT; BREAST CANCER MET.HER-2 +VE-ADVERSE REACTION MANAGEMENT; BREAST CANCER MET.HER-2 -VE-ADVERSE REACTION MANAGEMENT; COLORECTAL CANCER-CHOLINERGIC SIDE EFFECTS; DIARRHEA; ESOPHAGEAL CANCER-CHOLINERGIC SIDE EFFECTS; GASTRIC CANCER-CHOLINERGIC SIDE EFFECTS; HUMAN IMMUNODEFICIENCY VIRUS; IRRITABLE BOWEL SYNDROME; TRAVELLER'S DIARRHEA; VIRAL GASTROENTERITIS

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
IMODIUM A-D	1MG/7.5ML	solution · oral	KENVUE BRANDS	Over-the-counter	1 Mar 1988
IMODIUM A-D	2MG	tablet · oral	KENVUE BRANDS	Over-the-counter	22 Nov 1989
LOPERAMIDE HYDROCHLORIDE	2MG	capsule · oral	MYLAN	Prescription	18 Sep 1991
LOPERAMIDE HYDROCHLORIDE	2MG	capsule · oral	TEVA	Prescription	30 Apr 1992
LOPERAMIDE HYDROCHLORIDE	2MG	tablet · oral	OHM LABS	Over-the-counter	10 Dec 1992
LOPERAMIDE HYDROCHLORIDE	2MG	tablet · oral	L PERRIGO CO	Over-the-counter	6 Jan 2000
LOPERAMIDE HYDROCHLORIDE	2MG	tablet · oral	LNK	Over-the-counter	10 Jun 2003
LOPERAMIDE HYDROCHLORIDE	1MG; 2MG	capsule · oral	BIONPHARMA	Over-the-counter	4 Aug 2005
LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	solution · oral	PERRIGO R AND D	Over-the-counter	20 May 2011
LOPERAMIDE HYDROCHLORIDE	2MG	tablet · oral	AUROBINDO PHARMA	Over-the-counter	15 Dec 2015
LOPERAMIDE HYDROCHLORIDE	2MG	capsule · oral	ONESOURCE	Over-the-counter	11 Aug 2021
LOPERAMIDE HYDROCHLORIDE	2MG	capsule · oral	EDENBRIDGE PHARMS	Prescription	6 Oct 2021
LOPERAMIDE HYDROCHLORIDE	2MG	capsule · oral	BIONPHARMA	Prescription	22 Oct 2021
LOPERAMIDE HYDROCHLORIDE	2MG	capsule · oral	RUBICON RESEARCH	Prescription	26 Jan 2023
LOPERAMIDE HYDROCHLORIDE	2MG	capsule · oral	ZYDUS LIFESCIENCES	Prescription	23 Mar 2023
LOPERAMIDE HYDROCHLORIDE	2MG	capsule · oral	JUBILANT CADISTA	Prescription	5 Jul 2023
LOPERAMIDE HYDROCHLORIDE	2MG	capsule · oral	AUROBINDO PHARMA LTD	Prescription	5 Sep 2023
LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	solution · oral	BIONPHARMA	Over-the-counter	19 Sep 2025
LOPERAMIDE HYDROCHLORIDE	2MG	tablet · oral	PHARMAZONE	Over-the-counter	17 Nov 2025
LOPERAMIDE HYDROCHLORIDE	2MG	capsule · oral	AUROBINDO PHARMA	Over-the-counter	29 Dec 2025
LOPERAMIDE HYDROCHLORIDE	2MG	capsule · oral	TARO	Over-the-counter	30 Sep 2026
IMODIUM	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	capsule · oral	J AND J CONSUMER INC	Discontinued	28 Dec 1976
IMODIUM	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	capsule · oral	J AND J CONSUMER INC	Discontinued	28 Dec 1976
IMODIUM	1MG/5ML	solution · oral	JANSSEN PHARMS	Discontinued	31 Jul 1984
IMODIUM A-D	1MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	solution · oral	KENVUE BRANDS	Discontinued	1 Mar 1988

15 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
DIARRHEA RELIEF	02248994	2 MG	TABLET · ORAL	PHARMASCIENCE INC
DIARRHEA RELIEF	02256452	2 MG	TABLET · ORAL	VITA HEALTH PRODUCTS INC
DIARRHEA RELIEF FAST DISSOLVE	02499517	2 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	JUNO OTC INC
DIARRHEA RELIEF LIQUID GELS	02552337	2 MG	CAPSULE · ORAL	LABORATOIRE RIVA INC.
DIARRHEA RELIEF LIQUID GELS	02553139	2 MG	CAPSULE · ORAL	ANGITA PHARMA INC.
IMODIUM CALMING LIQUID	02291800	2 MG / 15 ML	SOLUTION · ORAL	KENVUE CANADA INC.
IMODIUM LIQUI-GELS	02376016	2 MG	CAPSULE · ORAL	KENVUE CANADA INC.
IMODIUM QUICK DISSOLVE	02230542	2 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	KENVUE CANADA INC.
JAMP LOPERAMIDE	02544989	2 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION
LOPERAMIDE-2	02225182	2 MG	TABLET · ORAL	PRO DOC LIMITEE
PMS-LOPERAMIDE - CAPLET 2MG	02228351	2 MG	TABLET · ORAL	PHARMASCIENCE INC
PMS-LOPERAMIDE HYDROCHLORIDE SOLUTION.2MG/ML	02016095	0.2 MG / ML	SOLUTION · ORAL	PHARMASCIENCE INC
RIVA-LOPERAMIDE	02238211	2 MG	TABLET · ORAL	LABORATOIRE RIVA INC.
TEVA-LOPERAMIDE	02132591	2 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	LOPERAMIDE 1 MG/7.5 ML SOLN	$0.02644	per ML	23 Sep 2026
US NADAC	LOPERAMIDE 2 MG CAPSULE	$0.0549	per EA	23 Sep 2026
NHS Drug Tariff	Loperamide 2mg capsules	£0.85	30 capsule	1 Oct 2026
NHS Drug Tariff	Loperamide 2mg oral lyophilisates sugar free	£5.19	12 tablet	1 Oct 2026
NHS Drug Tariff	Loperamide 2mg orodispersible tablets sugar free	£3.39	6 tablet	1 Oct 2026
NHS Drug Tariff	Loperamide 2mg orodispersible tablets sugar free	£5.21	12 tablet	1 Oct 2026
NHS Drug Tariff	Loperamide 2mg tablets	£1.97	30 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

2.3. Medicines for other common symptoms in palliative care · core
Palliative care
Oral > Solid > dosage form: 2 mg

Safety signals and safety-related labeling changes

US FDA 7 Aug 2019 IMODIUM A-D — safety-related labeling change
Labeling sections changed: Warnings and Precautions
EMA PRAC 14 Jun 2019 PRAC signal: Brugada syndrome in the context of abuse with loperamide
Action for MAH: update of the product information: Yes
EMA PRAC 11 Apr 2019 PRAC signal: Brugada syndrome in the context of abuse with loperamide
Action for MAH: update of the product information: No
US FDA 7 Mar 2019 IMODIUM A-D — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 11 Dec 2018 IMODIUM MULTI-SYMPTOM RELIEF — safety-related labeling change
Labeling sections changed: Warnings and Precautions
MHRA 26 Sep 2017 Loperamide (Imodium): reports of serious cardiac adverse reactions with high doses of loperamide associated with abuse or misuse
There have been reports of cardiac events including QT prolongation, torsades de pointes, and cardiac arrest in patients who have taken high or very high doses of loperamide as a drug of abuse or for self-treatment of opioid withdrawal.
US FDA 12 Apr 2017 IMODIUM A-D EZ CHEWS — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 12 Apr 2017 IMODIUM MULTI-SYMPTOM RELIEF — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 9 Mar 2017 LOPERAMIDE HYDROCHLORIDE — safety-related labeling change
Labeling sections changed: Warnings and Precautions
EMA PRAC 9 Mar 2017 PRAC signal: Serious cardiac events with high doses of loperamide from abuse and misuse
Action for MAH: update of the product information: Yes
US FDA 3 Nov 2016 IMODIUM — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions
US FDA 3 Nov 2016 IMODIUM — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions
EMA PRAC 8 Jul 2016 PRAC signal: Serious cardiac events with high doses of loperamide from abuse and misuse
Action for MAH: update of the product information: No

All safety entries for loperamide →

Combinations containing Loperamide

Loperamide + simeticone

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.